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NCT Number: NCT07383584

The Impact of Extending Sleep Before Joint-replacement Surgery on Post-surgical Pain

This study will evaluate the impact of sleep banking on joint replacement surgery recovery.

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Key information

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location contact

DVCIPM Clinical Research Nurse Manager

CONTACT

[email protected]

About this study

Sleep is emerging as a target for pain management. The purpose of this study is to determine the feasibility and efficacy of extending sleep (sleep "banking") on self-reported pain outcomes post-surgery. This is a prospective, interventional, between-subjects, randomized study with a control condition. Participants will be patients undergoing knee or hip replacement surgery at Naval Medical Center San Diego. Participants will be randomized to either a sleep banking group, where they attempt to extend nightly sleep in the week leading up to surgery, or to a habitual sleep control group, sleeping in their typical pattern for that same period. Sleep and pain will be monitored daily yn the two weeks pre- and one week post-surgery. After that, they will be sent electronic follow-up sleep and pain questionnaires at 1, 3, 6, 9, and 12 weeks post-surgery. Participants in the sleep banking group will also complete additional questionnaire items on the feasibility and implementation of the sleep banking protocol. Feasibility of sleep banking will be assessed by examination of the sleep between groups during the intervention week, as well as by the analysis of the implementation questions. Efficacy will be assessed by examination of self-reported pain outcomes post-surgery by group. The primary hypothesis is that self-reported pain outcomes will be improved in the sleep banking group as compared to the control group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals scheduled for a joint replacement surgery (knee or hip) at Naval Medical Center San Diego
  • Aged 18-74 years

Exclusion criteria

  • Individuals < 18 or >74 years of age at enrollment
  • Individuals diagnosed with untreated sleep disorders
  • Individuals with scheduled timezone travel or work schedule changes (>/= 3 hour time change) in the two weeks before surgery

Treatment and study plan

Sleep banking

Behavioral

The sleep extension group will add 2 hour of sleep per night the week before surgery

Primary outcomes

  1. Pain Intensity

    Time frame: Weeks 1-15

    Defense and Veterans Pain Rating Scale. On a scale of 0-10, with higher scores denoting more pain.

  2. Pain Medication Use

    Time frame: Weeks 1-15

    Opioid Use Diary

Secondary outcomes

  1. Physical Function

    Time frame: Weeks 1-15

    Patient-Reported Outcomes Measurement Information System (PROMIS) -29 Adult Profile 2.0 Instrument, Physical Function subscale. Each item is scored on a scale 1-5, with 1=without any difficulty and 5=unable to do. Items will be summed and t-scored (0-100), with higher scores denoting less function.

  2. Sleep Disturbance

    Time frame: Weeks 1-15

    Patient-Reported Outcomes Measurement Information System (PROMIS) -29 Adult Profile 2.0 Instrument, Sleep Disturbance subscale. Each item is scored on a scale 1-5, with 1=not at all and 5=very much. Items will be summed and t-scored (0-100), with higher scores denoting more sleep disturbance.

Study contacts

Contact information is provided by the study sponsor or research team.

Mary McDuffie, MS RN

CONTACT

[email protected]

3015388785

Sponsors and collaborators

Lead sponsor

Defense and Veterans Center for Integrative Pain Management

Other

Registry information

Official study title

Sleep Banking Pre-Surgery for Improved Chronic Post-Surgical Pain: A Pilot Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 3, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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